FDA Approval Status of Lexapro for Generalized Anxiety Disorder in Adolescents
Lexapro (escitalopram) is NOT FDA-approved for generalized anxiety disorder in adolescents—it is only FDA-approved for GAD in adults. 1
FDA-Approved Indications for Escitalopram
- Escitalopram is FDA-approved for major depressive disorder in adolescents aged 12-17 years 1
- Escitalopram is FDA-approved for generalized anxiety disorder in adults only, not in pediatric populations 1
- The FDA label explicitly states that "safety and effectiveness of Escitalopram has not been established in pediatric patients less than 18 years of age with Generalized Anxiety Disorder" 1
Evidence Supporting Off-Label Use in Adolescents with GAD
Despite the lack of FDA approval for pediatric GAD, substantial evidence supports escitalopram's efficacy in this population:
- A 2023 multicenter randomized controlled trial demonstrated that escitalopram (10-20 mg daily) was superior to placebo in reducing GAD symptoms in children and adolescents aged 7-17 years, with a statistically significant difference in PARS severity scores (p = 0.028) 2
- The American Academy of Child and Adolescent Psychiatry guidelines support both escitalopram and sertraline as first-line pharmacotherapy for anxiety in adolescents aged 6-18 years, despite the lack of FDA approval for pediatric GAD 3
- Escitalopram is well-tolerated in pediatric patients with GAD, with discontinuation rates due to adverse events not differing from placebo 2
FDA-Approved Alternative for Pediatric GAD
- Duloxetine (Cymbalta) is the only FDA-approved medication for GAD in pediatric patients aged 7-17 years, with dosing of 30-120 mg daily 3
- Duloxetine demonstrated superiority over placebo on the Pediatric Anxiety Rating Scale in a 10-week randomized controlled trial 3
Clinical Practice Recommendations
- The American Academy of Child and Adolescent Psychiatry recommends SSRIs such as escitalopram and sertraline for patients aged 6-18 years with GAD, acknowledging their off-label status but strong evidence base 3
- Combination treatment with cognitive behavioral therapy (CBT) plus an SSRI provides superior outcomes to either treatment alone, with 12-20 structured CBT sessions recommended 3, 4
- Escitalopram dosing for adolescents with GAD is typically 10-20 mg daily, consistent with adult dosing 2
Critical Monitoring Requirements
- All adolescents on escitalopram require monitoring for suicidal thinking and behavior, especially in the first months and after dose changes, with a pooled risk of 1% versus 0.2% for placebo 3
- Regular monitoring of weight and growth should be performed in children and adolescents treated with escitalopram, as decreased appetite and weight loss have been observed with SSRIs 1